Unitary surgical device and method

ABSTRACT

Unitary surgical devices ( 10 ) are disclosed. One group of the illustrated devices has a pair of biocompatible, bioresorbable anchors ( 16, 18 ) connected to fixed lengths suture. The anchors ( 16, 18 ) and fixed length of suture are connected to each other prior to surgery. Another group of unitary surgical devices has a pair of fixating mechanisms ( 15, 17 ) connected to a base ( 21 ) prior to surgery. The second group of illustrated devices generally includes extracellular matrix material either as part of the base ( 21 ) or supported on the base ( 21 ). The extracellular matrix material serves as tissue regenerating material. In the second group of unitary surgical devices, the fixating mechanisms illustrated generally comprise suture, anchors or pre-formed holes in the base. All of the illustrated unitary surgical devices are useful in repairing a damaged meniscus. The first group of unitary surgical devices can be used to approximate inner surfaces of a tear in the meniscus. The second group of devices can be used either as an insert to be placed between and approximated to the inner surfaces of the tear or as an insert to replace a void in the meniscus left after a menisectomy.

CROSS REFERENCE TO RELATED APPLICATIONS

Cross reference is made to copending U.S. patent applications Ser. No.10/195,794 entitled “Meniscus Regeneration Device and Method” (AttorneyDocket No. 265280-71141, DEP-745); Ser. No. 10/195,719 entitled “Devicesfrom Naturally Occurring Biologically Derived Materials” (AttorneyDocket No. 265280-71142, DEP-748); Ser. No. 10/195,347 entitled“Cartilage Repair Apparatus and Method” (Attorney Docket No.265280-71143, DEP-749); Ser. No. 10/195,341 entitled “HybridBiologic/Synthetic Porous Extracellular Matrix Scaffolds” (AttorneyDocket No. 265280-71144, DEP-751); Ser. No. 10/195,606 entitled“Cartilage Repair and Regeneration Device and Method” (Attorney DocketNo. 265280-71145, DEP-752); Ser. No. 10/195,354 entitled “PorousEktracellular Matrix Scaffold and Method” (Attorney Docket No.265280-71146, DEP-747); Ser. No. 10/195,334 entitled “Cartilage Repairand Regeneration Scaffolds and Method” (Attorney Docket No.265280-71180, DEP-763); Serial No. 10/195,633 entitled “Porous DeliveryScaffold and Method” (Attorney Docket No. 265280-71207, DEP-762), eachof which is assigned to the same assignee as the present application,each of which is filed concurrently herewith, and each of which ishereby incorporated by reference. Cross reference is also made to U.S.patent application Ser. No. 10/172,347 entitled “HybridBiologic-Synthetic Bioabsorbable Scaffolds” which was filed on Jun. 14,2002, which is assigned to the same assignee as the present application,and which is hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgical devices forapproximating, repairing or regenerating damaged or diseasedfibrocartilage, and to surgical methods using such devices.

BACKGROUND OF THE INVENTION

Articular cartilage is a type of hyaline cartilage that lines thesurfaces of the opposing bones in a diarthrodal joint (e.g., knee, hip,shoulder, etc.). Articular cartilage provides a near frictionlessarticulation between the bones, while also functioning to absorb andtransmit the compressive and shear forces encountered in the joint.Further, since the tissue associated with articular cartilage isaneural, these load absorbing and transmitting functions occur in apainless fashion in a healthy joint.

Human joints also have another type of cartilage present:intra-articular fibrocartilage. Intra-articular fibrocartilage can bepresent in the form of a discus articularis, that is, as a plate or ringof fibrocartilage in the joint capsule separating the joint surfaces(articular cartilage) of the bones of the joint. Such fibrocartilage ispresent, for example, in the temporomandibular joint, between vertebrae,and in the knee joint. In the knee joint, the intra-articularfibrocartilage comprises the meniscus, a crescent-shaped orsemi-lunar-shaped disc of tissue that is located between the femoralcondyles and the tibial plateau. The meniscus primarily functions as ashock absorber, absorbing the shock of compressive and shear forces inthe knee. The meniscus also provides a substantially frictionlesssurface for articulation of the knee joint.

When cartilage tissue is no longer healthy, there can be debilitatingpain in the joint. Cartilage health can be adversely affected bydisease, aging, or trauma. The adverse effects of disease, aging andtrauma can be in the form of a tear in the cartilage or in the form of abreakdown of the cartilage matrix.

In the knee, the meniscus is frequently damaged in twisting injuries. Itis also damaged with repetitive impact over time. Meniscus degenerationcan also occur by aging; as a person ages, the meniscus can become softin places, so that even common motions like squatting can cause meniscaltears.

Common surgical procedures for treating meniscal damage include tearrepairs and meniscectomies. A tear repair is most commonly performedwhen the tear is a clean longitudinal vertical lesion in the vascularred zone of the meniscus. The basic strategy is to stabilize the tear bylimiting or eliminating radial separation of the faces of the tear whenthe meniscus is load bearing. Many devices and surgical procedures existfor repairing meniscal tears by approximating the faces of the meniscusat the tear. Examples of such devices and procedures are disclosed inthe following U.S. Pat. Nos.: 6,319,271; 6,306,159; 6,306,156;6,293,961; 6,156,044; 6,152,935; 6,056,778; 5,993,475; 5,980,524;5,702,462; 5,569,252; 5,374,268; 5,320,633; and 4,873,976.

Meniscectomies involve the surgical removal of part of the meniscus.Such procedures have generally been performed in cases of radial tears,horizontal tears, vertical longitudinal tears outside the vascular zone,complex tears, or defibrillation. Although meniscectomies provideimmediate relief to the patient, in the long term the absence of part ofthe meniscus can cause cartilage wear on the condylar surface,eventually leading to arthritic conditions in the joint.

U.S. Pat. No. 6,042,610 assigned to ReGen Biologics, Inc., herebyincorporated by reference, discloses the use of a collagen scaffolddevice comprising a bioabsorbable material made at least in part frompurified natural fibers. The purified natural fibers are cross-linked toform the device of that patent. The device produced can be used toprovide augmentation for a damaged meniscus. Related U.S. Pat. Nos.6,042,610; 5,735,903; 5,681,353; 5,306,311; 5,108,438; 5,007,934;4,880,429 also disclose a meniscal augmentation device for establishinga scaffold adapted for ingrowth of meniscal fibrochondrocytes.

It is also known to use naturally occurring extracelluar matrices (ECMs)to provide a scaffold for tissue repair and regeneration. One such ECMis small intestine submucosa (SIS). SIS has been described as a naturalbiomaterial used to repair, support, and stabilize a wide variety ofanatomical defects and traumatic injuries. See, for example, Cook®Online News Release provided by Cook Biotech Inc. at“www.cookgroup.com”. The SIS material is derived from porcine smallintestinal submucosa that models the qualities of its host whenimplanted in human soft tissues. Further, it is taught that the SISmaterial provides a natural matrix with a three-dimensional structureand biochemical composition that attracts host cells and supports tissueremodeling. SIS products, such as OASIS™ and SURGISIS™, are commerciallyavailable from Cook Biotech Inc., Bloomington, Ind.

Another SIS product, RESTORE® Orthobiologic Implant, is available fromDePuy Orthopaedics, Inc. in Warsaw, Ind. The DePuy product is describedfor use during rotator cuff surgery, and is provided as a resorbableframework that allows the rotator cuff tendon to regenerate. The RESTOREImplant is derived from porcine small intestine submucosa, a naturallyoccurring ECM composed primarily of collagenous proteins, that has beencleaned, disinfected, and sterilized. Other biological molecules, suchas growth factors, glycosaminoglycans, etc., have also been identifiedin SIS. See: Hodde et al., Tissue Eng., 2(3): 209-217 (1996);Voytik-Harbin et al., J. Cell. Biochem., 67: 478-491 (1997); McPhersonand Badylak, Tissue Eng., 4(1): 75-83 (1998); Hodde et al., Endothelium8(1): 11-24; Hodde and Hiles, Wounds, 13(5): 195-201 (2001); Hurst andBonner, J. Biomater. Sci. Polym. Ed., 12(11): 1267-1279 (2001); Hodde etal., Biomaterial, 23(8): 1841-1848 (2002); and Hodde, Tissue Eng., 8(2):295-308 (2002). During seven years of preclinical testing in animals,there were no incidences of infection transmission from the implant tothe host, and the SIS material has not adversely affected the systemicactivity of the immune system. See: Allman et al., Transplant, 17(11):1631-1640 (2001); Allman et al., Tissue Eng., 8(1):53-62 (2002).

While small intestine submucosa is available, other sources of ECM areknown to be effective for tissue remodeling. These sources include, butare not limited to, stomach, bladder, alimentary, respiratory, andgenital submucosa. In addition, liver basement membrane is known to beeffective for tissue remodeling. See, e.g., U.S. Pat. Nos. 6,379,710,6,171,344, 6,099,567, and 5,554,389, hereby incorporated by reference.Further, while ECM is most often porcine derived, it is known that thesevarious ECM materials can be derived from non-porcine sources, includingbovine and ovine sources. Additionally, the ECM material may alsoinclude partial layers of laminar muscularis mucosa, muscularis mucosa,lamina propria, stratum compactum layer and/or other such tissuematerials depending upon other factors such as the source from which theECM material was derived and the delamination procedure.

The following U.S. patents, hereby incorporated by reference, disclosethe use of ECMs for the regeneration and repair of various tissues: U.S.Pat. Nos. 6,379,710; 6,187,039; 6,176,880; 6,126,686; 6,099,567;6,096,347; 5,997,575; 5,993,844; 5,968,096; 5,955,110; 5,922,028;5,885,619; 5,788,625; 5,733,337; 5,762,966; 5,755,791; 5,753,267;5,711,969; 5,645,860; 5,641,518; 5,554,389; 5,516,533; 5,460,962;5,445,833; 5,372,821; 5,352,463; 5,281,422; and 5,275,826.

SUMMARY OF THE INVENTION

The present invention is directed toward devices and surgical methodsfor the repair and regeneration of diseased or damaged intra-articularfibrocartilage such as the meniscus in the human knee joint.

In one aspect, the present invention provides a unitary surgical devicefor implantation in a patient for repairing a body tissue in thepatient. The unitary surgical device comprises first and secondbiocompatible anchors and biocompatible tissue repair material extendingbetween and connected to the first and second anchors. The anchors andtissue repair material are connected to each other prior to surgery. Thefirst anchor includes at least one of the following: a bioresorbablebarbed dart; a bioresorbable tack; a bioresorbable backstop; and abioresorbable male locking member. The second anchor includes at leastone of the following: a bioresorbable barbed dart; a bioresorbable tack;a bioresorbable backstop; and a bioresorbable female locking member. Thebiocompatible tissue repair material includes at least one of thefollowing: a fixed length of suture; a sheet of collagen-containingmaterial; laminar ECM material; formed ECM material; comminuted ECMmaterial; ECM fibers; ECM foam material; a sheet of bioresorbablematerial; and a base connected to the first anchor and to the secondanchor and a different material secured to the base, at least one of thebase and the different material including ECM material.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regeneratingintra-articular fibrocartilage tissue in the patient. The unitarysurgical device comprises a first fixating mechanism, a second fixatingmechanism and tissue repair material extending between and connected tothe first and second fixating members prior to surgery. The firstfixating mechanism includes at least one of the following: a length ofsuture; a bioresorbable barbed dart; a bioresorbable tack; abioresorbable backstop; and a bioresorbable male locking member. Thesecond fixating mechanism includes at least one of the following: alength of suture; a bioresorbable barbed dart; a bioresorbable tack; abioresorbable backstop; and a bioresorbable female locking member. Thetissue repair material includes at least one of the following: a sheetof ECM material connected to the first anchor and the second anchor;laminar ECM material connected to the first anchor and the secondanchor; ECM foam; comminuted ECM; ECM fibers; cross-linked ECM material;formed ECM material; and a bioresorbable base connected to the firstanchor and the second anchor and a different material on the base, whereat least one of the base and the different material includes ECM.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regeneratingintra-articular fibrocartilage tissue in the patient. The unitarysurgical device comprises a base having at least two layers and a lengthof suture disposed or positioned between the layers of the base. Atleast part of the unitary surgical device is made from ECM material.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regenerating meniscaltissue in the patient. The unitary surgical device comprises a basehaving two panels. The two panels have a V-shaped configuration incross-section, and meet along an apex portion. The two panels have endportions spaced distally from the apex portion. The end portions arespaced from each other to provide a gap. The unitary surgical device mayalso include tissue regeneration material between the two panels of thebase. The unitary surgical device also includes opposing anchors on theend portions of the base panels. The opposing anchors are suitable forfixation to the native meniscus.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regenerating tissue inthe patient. The unitary surgical device comprises a base made of abioresorbable polymer and ECM material on the base. In addition, theunitary surgical device includes a first fixating member secured to thebase prior to surgery. The first fixating member is suitable forfixation to the patient's tissue.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regenerating tissue inthe patient. The unitary surgical device comprises a base made of ECMmaterial and a first fixating member secured to the base prior tosurgery. The first fixating member is suitable for fixation to thepatient's tissue.

In another aspect, the present invention provides a unitary surgicaldevice for surgical implantation in a patient for regenerating tissue inthe patient. The unitary surgical device comprises a base having twoopposing edges and a plurality of holes along one of the edges of thebase. The unitary surgical devices includes ECM material.

In another aspect, the present invention provides a method of repairinga tear in the meniscus in the knee of a patient. The meniscus has anarticulating surface and a non-articulating surface. The tear results inthe meniscus having two inner surfaces. The method comprises the acts ofproviding a unitary surgical device having a pair of resorbable anchorsand a fixed length of suture connected to the anchors. After the tear inthe meniscus is located, the unitary surgical device is implanted toapproximate the two inner surfaces of the meniscus at the tear, withsuture extending across the articulating surface of the meniscus acrossthe tear and the resorbable anchors being spaced from the tear.

In another aspect, the present invention provides a method of repairinga damaged meniscus in the knee of a patient. The meniscus has anon-articulating surface, a peripheral rim and an inner portion. Themethod comprises the acts of providing a wedge-shaped unitary surgicaldevice including a fixating mechanism. A portion of the damaged meniscusinward of the peripheral rim of the meniscus is removed. The unitarysurgical device is implanted with a portion inward of the peripheralrim. The unitary surgical device is fixated to the meniscus by fixatingat least part of the base of the unitary surgical device to the meniscuswith the fixating mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood by reference to the figures ofthe drawings wherein like numbers denote like parts throughout andwherein:

FIG. 1 is a diagrammatic perspective view of a meniscus with a tear;

FIG. 2 is a cross-section taken along line 2-2 of the meniscus of FIG.1;

FIG. 3 is a perspective view of a first embodiment of a unitary surgicaldevice of the present invention;

FIG. 4 is a cross-section of a torn meniscus showing the unitarysurgical device of FIG. 3 fixated to the meniscus;

FIG. 5 is a perspective view of a second embodiment of a unitarysurgical device of the present invention;

FIG. 6 is a cross-section of a torn meniscus showing the unitarysurgical device of FIG. 5 fixated to the meniscus;

FIG. 7 is a perspective view of a third embodiment of a unitary surgicaldevice of the present invention;

FIG. 8 is a cross-section of a torn meniscus showing the unitarysurgical device of FIG. 7 fixated to the meniscus;

FIG. 9 is a perspective view of a fourth embodiment of a unitarysurgical device of the present invention;

FIG. 10 is a cross-section of a torn meniscus showing the unitarysurgical device of FIG. 9 fixated to the meniscus;

FIG. 11 is an elevation of a fifth embodiment of a unitary surgicaldevice of the present invention;

FIG. 12 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 11 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 13 is a top plan view of a sixth embodiment of a unitary surgicaldevice of the present invention;

FIG. 14 is an elevation of the unitary surgical device of FIG. 13;

FIG. 15 is a perspective diagrammatic view of a meniscus, with a voidleft by a partial meniscectomy and with the unitary surgical device ofFIGS. 13-14 in the process of being implanted;

FIG. 16 is a perspective diagrammatic view of the meniscus of FIG. 15,shown with the unitary surgical device of FIGS. 13-15 fixated to themeniscus;

FIG. 17 is a cross-section of the meniscus and unitary surgical deviceof FIG. 16, taken along line 17-17 of FIG. 16;

FIG. 18 is a top plan view of a seventh embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 19 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 18 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 20 is an elevation of an eighth embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 21 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 20 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 22 is a top plan view of a ninth embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 23 is a perspective view of the unitary surgical device of FIG. 22,shown with the top panel of the base folded over the mass of tissueregeneration material;

FIG. 24 is a perspective diagrammatic view of a meniscus, with a voidleft by a partial meniscectomy;

FIG. 25 is a perspective diagrammatic view of a meniscus, with a voidleft by a partial meniscectomy and with the unitary surgical device ofFIGS. 22-23 in the process of being implanted;

FIG. 26 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIGS. 22-23 and 25 fixated to themeniscus and at least partially filling the void left by the partialmeniscectomy;

FIG. 27 is a top plan view of a tenth embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 28 is a bottom plan view of an eleventh embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 29 is a perspective, partially cut-away view of a meniscus with theunitary surgical device of FIG. 27 fixated to the meniscus;

FIG. 29A is a bottom plan view of a twelfth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 29B is a side elevation of the embodiment of FIG. 29A;

FIG. 30 is a perspective view of a thirteenth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 31 is a is a cross-section of a meniscus, after a partialmeniscectomy, showing the unitary surgical device of FIG. 30 fixated tothe meniscus and at least partially filling the void left by the partialmeniscectomy;

FIG. 32 is an elevation of a fourteenth embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 33 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 32 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 34 is a perspective view of a fifteenth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 35 is an elevation of a sixteenth embodiment of a unitary surgicaldevice incorporating the teachings of the present invention;

FIG. 36 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 35 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 37 is an elevation of a seventeenth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 38 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 37 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 39 is an elevation of an eighteenth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 40 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 39 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy;

FIG. 41 is an enlarged cross-section through a part of a laminar base ofa unitary surgical device, such as the device of FIG. 35, with animplanted tack used as one of the anchors of the device;

FIG. 42 is a perspective view of a nineteenth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 43 is an enlarged plan view of a mesh used as the base of a unitarysurgical device;

FIG. 44 is a top plan view of a twentieth embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 45 is a top plan view of a twenty-first embodiment of a unitarysurgical device incorporating the teachings of the present invention;

FIG. 46 is a cross-section through a torn meniscus, showing the unitarysurgical device of FIG. 44 in place within the meniscal tear prior toapproximation of the tissue;

FIG. 47 is a cross-section through a torn meniscus, showing the unitarysurgical device of FIG. 45 in place within the meniscal tear prior toapproximation of the tissue;

FIG. 48 is a cross-section through a torn meniscus, showing the unitarysurgical device of FIGS. 44 and 47 in place within the meniscal tearafter approximation of the meniscal tissue;

FIG. 49 is a cross-section through a torn meniscus, showing the unitarysurgical device of FIGS. 45 and 48 in place within the meniscal tearafter approximation of the meniscal tissue;

FIG. 50 is a perspective view of a twenty-second embodiment of theunitary surgical device of the present invention;

FIG. 51 is a perspective view of a portion of a meniscus, showing theunitary surgical device of FIG. 50 in use in repairing a tear in themeniscus;

FIG. 52 is a cross-section of a meniscus, after a partial meniscectomy,showing the unitary surgical device of FIG. 37 fixated to the meniscusand at least partially filling the void left by the partialmeniscectomy; and

FIG. 53 is a perspective view of a twenty-third embodiment of theunitary surgical device of the present invention, in place on ameniscus.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

A variety of unitary surgical devices 10 utilizing the principles of thepresent invention are illustrated in the accompanying drawings. Theillustrated surgical devices 10 are for implantation in a patient forrepairing a body tissue in the patient. The illustrated embodimentswould most commonly be used in repairing intra-articular fibrocartilage,such as the meniscus of the knee, although the invention is not solimited unless expressly called for in the claims. A meniscus, or partof a meniscus, is diagrammatically illustrated at 12 in the accompanyingdrawings (FIGS. 1-2, 4, 6, 8, 10, 12, 15-17, 19, 21, 24-26, 29, 31, 33,36, 38, 40, 46-49, 51 and 52). An example of a meniscal tear is shown at14 in FIGS. 1-2, 4, 6, 8, 10, 46, 47 and 51. The invention is alsoexpected to be useful in the treatment of damaged and diseasedintra-articular fibrocartilage in other body parts as well.

As used herein “unitary” refers to the fact that the surgical devices 10include at least one fixating element 15 and at least one tissue repairelement 20, as an integral unit, prior to the time that the surgicaldevices are implanted in the patient. Preferably, each unitary surgicaldevice 10 also includes a second fixating element 17. Thus, for example,suture may be incorporated into the device prior to the time the deviceis implanted in the patient. However, it should be understood thatalthough at least one of each element is included in the device, thesurgeon may choose to use additional material during surgery. Forexample, the surgeon may opt during surgery to use an additionalfixating mechanism that was not an integral part of the original device,if the surgeon believes that additional stabilization is necessary ordesirable.

As used herein, “tissue repair element” and “tissue repair material” areintended to include materials such as suture, whether of natural orsynthetic origin, as well as tissue or cartilage regeneration material.Tissue or cartilage regeneration material encompasses naturallyoccurring extracellular matrix (ECM) materials that provide a collagenscaffold for tissue repair and regeneration. One such ECM material thatmay be used for the tissue or cartilage regeneration material issubmucosa, and small intestine submucosa (SIS) in particular. Otherbioremodelable collagenous tissue matrices, whatever the source, areintended to be included within “tissue regeneration material”, includingpurified collagenous tissues. As used herein, “SIS” is intended toinclude small intestine submucosa unless otherwise limited. Moreover, asused herein, “ECM” is intended to include all SIS, as well as materialsmade from the other sources of submucosa identified above (e.g.,bladder, stomach and liver tissue from bovine, ovine and porcinesources) and materials derived from liver basement membrane (fromwhatever source) unless otherwise limited. For the purposes of thisinvention, it is within the definition of a naturally occurring ECM toclean, delaminate, and/or comminute the ECM, to cross-link the collagenwithin the ECM, and to form a foam or other structure from the ECM. Itis also within the definition of naturally occurring ECM to fully orpartially remove one or more components or subcomponents of thenaturally occurring matrix. However, it is not within the definition ofa naturally occurring ECM to extract or separate and purify the naturalcomponents or subcomponents (e.g., collagen or growth factor) and reforma matrix material from these extracted and purified components orsubcomponents. Also, while reference is made to SIS, it is understoodthat other naturally occurring ECMs such as stomach, bladder,alimentary, respiratory, and genital submucosa, and liver basementmembrane, for example, whatever the source (e.g., bovine, porcine,ovine, etc.) are within the scope of this invention. Thus, in thisapplication, the terms “naturally occurring extracellular matrix” or“naturally occurring ECM” are intended to refer to extracellular matrixmaterial that has been cleaned, disinfected, sterilized, and optionallycross-linked. The terms “naturally occurring ECM” and “naturallyoccurring extracellular matrix” are also intended to include foammaterial made from naturally occurring ECM as described in copendingU.S. patent application Ser. No. 10/195,354 entitled “PorousExtracellular Matrix Scaffold and Method” (Attorney Docket No.265280-71146, DEP-747), the toughened material made from naturallyoccurring ECM as described in U.S. patent application Ser. No.10/195,794 entitled “Meniscus Regeneration Device and Method” (AttorneyDocket No. 265280-71141, DEP-745), and the hardened material made fromnaturally occurring ECM as described in U.S. patent application Ser. No.10/195,719 entitled “Devices from Naturally Occurring BiologicallyDerived Materials” (Attorney Docket No. 265280-71142, DEP-748), allfiled concurrently herewith as U.S. Provisional Patent Applications andincorporated by reference below.

As used herein, bioresorbable, resorbable and bioabsorbable are intendedto be interchangeable. All three terms are intended to mean materialsthat are naturally degradable in vivo over time. All are intended toinclude both natural and man-made materials, and to include newmaterials as they are developed, unless a specific material or type ofmaterial is identified in the claims.

As used herein, “intra-articular fibrocartilage” is intended to includethe meniscus in the knee joint. It is also intended to includefibrocartilage separating the joint surfaces (articular cartilage) ofthe bones of other joints and separating the surfaces of adjacentvertebrae. “Intra-articular fibrocartilage” thus includes, for example,fibrocartilage in the temporomandibular joint and between vertebrae.Although the embodiments of the invention illustrated in FIGS. 11-23,25-42, 44-47 and 53 are shaped for use in the meniscus, it should beunderstood that the principles of the present invention may be appliedto surgical devices to be used in repairing and regenerating damaged ordiseased intra-articular fibrocartilage in other joints in the body.

ECM material, and combinations of ECM material and synthetic materials,for use in the present invention can be prepared as described in thefollowing United States Patents, utility applications for United Statespatents, and provisional applications for United States Patents, thedisclosures of which are incorporated by reference herein: U.S. Pat. No.4,902,508, entitled “Tissue Graft Composition”; U.S. Pat. No. 4,956,178,entitled “Tissue Graft Composition”; U.S. Pat. No. 5,281,422, entitled“Graft for Promoting Autogenous Tissue Growth”; U.S. Pat. No. 5,372,821,entitled “Graft for Promoting Autogenous Tissue Growth”; U.S. Pat. No.5,445,833, entitled “Tendon or Ligament Graft for Promoting AutogenousTissue Growth”; U.S. Pat. No. 5,733,337, entitled “Tissue RepairFabric”; U.S. Pat. No. 5,788,625, entitled “Method of MakingReconstructive SIS Structure for Cartilaginous Elements In Situ”; U.S.Pat. No. 5,922,028, entitled “Multi-layered SIS Tissue Graft Constructfor Replacement of Cartilaginous Elements In Situ”; U.S. Pat. No.5,955,110, entitled “Multilayered Submucosal Graft Constructs and Methodfor Making the Same”; U.S. Pat. No. 5,993,844, entitled “ChemicalTreatment, Without Detergents or Enzymes, of Tissue to Form an Acellularcollagenous Matrix”; U.S. Pat. No. 6,176,880, entitled “Tissue GraftConstruct for Replacement of Cartilaginous Structures”; U.S. PublicationNo. US-2002-0038151-A1, published Mar. 28, 2002, entitled “ReinforcedSmall Intestine Submucosa”; U.S. Publication No. US-2001-0002446-A1,published May 31, 2001, entitled “Tissue Graft Construct for Replacementof Cartilaginous Structures”; U.S. patent application Ser. No.09/767,346, filed Jan. 23, 2001, entitled “Tissue Graft Construct forReplacement of Cartilaginous Structures”; U.S. Provisional ApplicationSer. No. 60/305,786, entitled “Meniscus Regeneration Device and Method”,filed on Jul. 16, 2001.

The “ECM” for use in the present invention can be disinfected asdescribed in U.S. Pat. No. 6,206,931, entitled “Graft ProsthesisMaterials” or U.S. Pat. No. 5,460,962, entitled “Peracetic AcidSterilization of Collagen or collagenous Tissue,” which are incorporatedby reference herein in their entireties, or may be disinfected generallythrough the use of a disinfecting agent such as a 0.15% peracetic acidin 20% ethanol solution.

As described above, ECM material as used herein includes commerciallyavailable materials, unless otherwise expressly limited. Suchcommercially available materials include those available from DePuyOrthopaedics, Inc. of Warsaw, Ind. (e.g., RESTORED® OrthobiologicImplant), for example.

It should also be understood that “ECM” materials, including “SIS”, asused herein, are not limited to the materials or processes described inthe preceding paragraphs unless expressly indicated otherwise; thepatents, provisional applications, utility applications and commercialproducts identified in the preceding paragraphs are identified forpurposes of illustration only.

Referring now to the illustrated embodiments of the present invention,one group of unitary surgical devices 10 is illustrated in FIGS. 3-10and 50-52. As illustrated in FIGS. 3, 5, 7, 9 and 50, each unitarysurgical device 10 of this group includes two fixating elements 15, 17:a first anchor 16 and a second anchor 18. Each unitary surgical devicealso includes tissue repair material 20 extending between and connectedto the first anchor 16 and second anchor 18. The tissue repair material20 is connected to the two fixating members 15, 17 prior to surgery, andprior to terminal sterilization of the unitary surgical devices. In thisgroup, the tissue repair material 20 comprises suture. A second group ofunitary surgical devices 10 is illustrated in FIGS. 11-23, 2540,42 and44-49. As illustrated in FIGS. 11, 13, 15, 18, 20, 22, 23, 27, 28, 30,34, 35, 37, 39, 44, 45 and 50, each illustrated unitary surgical device10 of this group also includes two fixating elements 15, 17 and tissuerepair material 20 extending between and connected to the fixatingmembers 15, 17. In this second group, the tissue repair material 20includes a tissue regeneration material 22; the tissue repair material20 may also include other elements such as suture or a base 21. Inaddition, in this second group, although the fixating elements 15, 17may include anchors 16, 18, the fixating elements may also includesuture, either alone or in combination with the anchors 16, 18. Thus,the fixating members 15, 17 may comprise: one or more anchors 16, 18;one or more anchors 16, 18 combined with suture 16 g, 18 g; or suture 16g, 18 g alone. All of these elements in the second group are securedtogether prior to surgery and prior to terminal sterilization of theunitary surgical devices.

In both groups of devices, where at least one of the fixating members15, 17 includes an anchor, the anchor 16 may comprise: a barbed dart, asillustrated at 16 a in FIGS. 3-4, 7-8, 9-10, 30-34 and 50-52; a tack, asillustrated at 16 b in FIGS. 35-36; a backstop, as illustrated at 16 cin FIGS. 5-6; a male locking member, as illustrated at 16 d in FIGS.37-40; or a pair of connected anchors such as the pair of barbed darts16 a connected by a length of suture. The first fixating member 15 mayalso comprise a length of suture, as shown at 16 g in FIGS. 11-15,17-23, 25-26, 28-29, 42 and 44. The first fixating member 15 may alsocomprise combinations of anchors and other materials, such as acombination of a barbed dart 16 a as an anchor and a length of suture 16g, as shown in FIGS. 30-31 and 46-47, or a combination of a male lockingmember 16d and a length of suture 16 g, as shown in FIGS. 39-40, forexample. Whatever form of fixating member is selected, each material inthe illustrated embodiments is a biocompatible and bioabsorbable one,that is, one that will eventually be broken down, assimilated, diminutedor excreted, or both assimilated and diminuted or excreted by the bodyof the patient. If a second fixating member 17 is used, it may include asecond anchor 18. The second anchor 18 may comprise a top hat-shapedfixating member, as illustrated at 18 a in FIGS. 3-4; a backstop, asillustrated at 18 b in FIGS. 5-8; barbed dart, as illustrated at 18 c inFIGS. 9-10, 27, 30-31 and 50-51; a receiving opening, as shown at 18 din FIG. 34; a tack, as illustrated at 18 e in FIGS. 35-36; a femalelocking member, as illustrated at 18 f in FIGS. 37-40. The secondfixating member 17 may also comprise a length of suture, as shown at 18g in FIGS. 13-23, 25-26, 28-29,42 and 44-45. The second fixating member17 may also comprise combinations of materials, such as a combination ofan anchor 18 such as a barbed dart 18 c and a length of suture 18 g, asshown in FIGS. 30-31 and 46-47, for example. As in the case of the firstfixating member 15, whatever structure or form is selected for thesecond fixating member 17, each material in the illustrated embodimentsis a biocompatible and bioabsorbable one.

In unitary surgical devices 10 using two fixating members 15, 17,various combinations of the above-described anchors 16 a-16 g, 18 a-18 gcan be used. For example, two anchors may be used of the same ordifferent shape, such as: a barbed dart 16 a with a top hat-shapedstructure 18 a, as shown in FIGS. 3-4; a barbed dart 16 a with anotherbarbed dart as shown at 16 a and 18 c in FIGS. 9-10; a barbed dart witha backstop, as shown at 16 a and 18 b in FIGS. 7-8; a tack 16 b can beused with another tack 18 e, as shown in FIGS. 35-36, or with some otherstructure. All of these combinations may be used with suture as thetissue repair material 20 in the first group of embodiments, and all ofthem may be used with the second group of embodiments as well. It shouldbe understood that these combinations are identified for purposes ofillustration only. The present invention is not limited to thesecombinations unless expressly set forth in the claims.

A variety of materials may be used for the first and second anchors 16,18. For example, the anchors may be constructed of biocompatiblepolymers, bioremodelable collagenous matrices and combinations of suchmaterials. Other materials, such as bioactive agents, other biologicallyderived agents, biocompatible inorganic materials, cells, and biologicallubricants can also be included as part of the anchors.

As used herein, “biocompatible polymer” and “biocompatible polymers” isintended to include both synthetic polymers and biopolymers (e.g.,collagen). Examples of biocompatible polymers include: polyesters of[alpha]-hydroxycarboxylic acids, such as poly(L-lactide) (PLLA) andpolyglycolide (PGA); poly-p-dioxanone (PDO); polycaprolactone (PCL);polyvinyl alcohol (PVA); polyethylene oxide (PEO); polymers disclosed inU.S. Pat. Nos. 6,333,029 and 6,355,699; and any other bioresorbable andbiocompatible polymer, co-polymer or mixture of polymers or co-polymersthat are utilized in the construction of prosthetic implants. If othersuch polymers have therapeutic value in the orthopaedic field, it isanticipated that at least some of them will have use in the presentinvention, and at least some of them should be included in“biocompatible polymers.” In addition, as new biocompatible,bioresorbable materials are developed, it is expected that at least someof them will be useful materials from which orthopaedic devices may bemade. It should be understood that the above materials are identified byway of example only, and the present invention is not limited to anyparticular material unless expressly called for in the claims.

“Bioremodelable collagenous tissue matrix” and “naturally occurringbioremodelable collagenous tissue matrix” are intended to includematrices derived from native tissue selected from the group comprisingskin, artery, vein, pericardium, heart valve, dura mater, ligament,bone, cartilage, bladder, liver, stomach, fascia and intestine, whateverthe source. Although “naturally occurring bioremodelable collagenoustissue matrix” is intended to refer to matrix material that has beencleaned, processed, sterilized, and optionally cross-linked, it is notwithin the definition of a naturally occurring bioremodelablecollagenous tissue matrix to extract and purify the natural componentsor subcomponents (e.g., collagen) and reform or reconstitute a matrixmaterial from purified natural components or subcomponents.

It is understood and intended that there is substantial overlap between“bioremodelable collagenous tissue matrices” and “extracellularmatrices”; the different expressions are used in this specification andclaims to ensure complete coverage of the invention. It is believed thatthe teachings of the present invention will be useful for materialsfalling with both definitions.

Some commercially available products may be used as the anchors 16, 18in some of the illustrated embodiments. For example, the backstopelements shown at 16 c, 18 b and 19 in FIGS. 5-8, 45, 47 and 50-52 andtop-hat-shaped element 18 a shown in FIGS. 3-4 may be taken from theRAPIDLOC™ Meniscal Repair System available from the MITEK® Productsdivision of ETHICON, INC. of Westwood, Mass.

In addition, the anchors 16 a-16 f, 18 a-18 f may be constructed from anaturally occurring material such as naturally occurring extracellularmatrices (ECM), such as small intestine submucosa (SIS). In such a case,each anchor 16 a-16 f, 18 a-18 f may be configured as a monolithicstructure formed from naturally occurring ECM which is cured to be rigidand hardened. As such, it should be appreciated that the ECM materialfrom which the anchor is fabricated is cured to produce a structure thatpossesses the necessary hardness and toughness to be inserted into andthrough the native meniscus and to be retained in the native meniscusfor at least a predetermined period of time.

ECM material with the necessary hardness and toughness for use as theanchors may be fabricated by compacting comminuted or shredded naturallyoccurring ECM material into bar or rod stock by compressing the materialtogether and then curing the material such that it is very rigid andhardened. The curing may be accomplished by simple air drying or byheated air drying of the formed stock. The material may additionally becross-linked to further improve its mechanical properties.

As a specific example, one or more of the anchors 16 a-16 f, 18 a-18 fmay be constructed with a cured and hardened SIS. In this case,comminuted SIS material is placed in a container and allowed to air dryfor a predetermined period of time (e.g., as long as several days) atroom temperature. Over such a time, water evaporates from the SISmaterial thereby shrinking the material. The shrunk material is verytough and hard and, as a result, may be machined as described herein.

It should be appreciated that other process parameters may beestablished to facilitate the curing process. For example, a curingprofile utilizing predetermined amounts of heat and/or pressure may bedesigned to facilitate the curing of the naturally occurring ECMmaterial (e.g., SIS).

Once the ECM material (e.g., SIS) is cured to a desired hardness andtoughness, it may be machined with conventional machining equipment todesired shapes such as in the shape of a barbed dart as illustrated inFIGS. 3-4, 7-10, 27, 30-33 and 46-47. For example, the anchor 16 a-16 f,18 a-18 f may be turned on a lathe or similar equipment to produce thedesired configuration of the anchor, such as the barbed darts. However,based on the specific design of the anchor, it should be appreciatedthat certain features of the anchor (e.g., the barbed darts) may beseparately or additionally machined to produce a desired shape orgeometry. For example, various barb configurations may be formed on partof the anchor, by, for example, use of a cutting machine.

In addition to conventional cutting machining techniques (e.g., lathingand cutting), contemporary techniques may also be utilized to form thecured naturally occurring ECM into the desired configuration of theanchor 16 a-16 f, 18 a-18 f. For example, a programmable laser cuttingmachine may be used to cut the raw stock of cured ECM. Specifically, thelaser cutting machine may be programmed to cut the raw stock in apattern which produces a desired configuration of the anchor. Inaddition to providing for cutting with precision tolerances, lasercutting also provides other benefits. Such laser cutting of the ECM canproduce barbed darts having cut edges which are sealed and fusedtogether to enhance the attachment capability of the barbed darts.

It should be understood that the material selected for the anchors 16a-16 f, 18 a-18 f may also comprise mixtures or composites of thematerials described above. For example, the anchors 16 a-16 f, 18 a-18 fcould comprise both a biocompatible polymer and ECM material. Withregard to the shape of the barbed darts 16 a, 18 c that may be used withthe present invention, reference is made to barbed dart configurationshown in U.S. Pat. No. 5,702,463 as one example of a shape of barbeddart that may be useful. It should be understood that the shapes of thebarbed darts 16 a, 18 c and other anchors 16 b-16 f, 18 a-18 b, 18 d-18f shown in the accompanying drawings are provided for purposes ofillustration only. The present invention is not limited to anyparticular shape of barbed dart or other anchor unless expressly setforth in the claims. It should also be understood that the sizes of theanchors in the drawings shown are provided for purposes of illustrationonly. The actual sizes of the anchors may be different from thoseillustrated, and may vary with the method used to implant them. Forexample, the commercially available backstop is inserted through aneedle, as shown in the Mitek Products document “RAPIDLOC MENISCALREPAIR SYSTEM, Surgical Technique for Repair of Meniscal Tears”. If thistechnique and instrumentation is to be used to insert the anchors of thepresent invention, then the anchors should be sized accordingly. Typicalbarbed darts can be expected to be in the range of about 1 mm in maximumdiameter and about 3 mm in length. It should be understood that thesedimensions are provided for purposes of illustration only; the presentinvention is not limited to any particular size of anchor unlessexpressly set forth in the claims.

Where the fixating elements 15, 17 include or consist of suture 16 g, 18g, such as in FIGS. 11-23, 25-31, 42 and 44, any suitable suturematerial may be used, such as commercially available suture. Acceptablesuture may be obtained from the MITEK PRODUCTS division of ETHICON, INC.of Westwood, Mass.; examples include PANACRYL™ absorbable suture,ETHIBOND® EXCEL polyester suture, PDS® polydioxanone suture and PROLENE®polypropylene suture.

Whatever structure and material is chosen for the anchors 16, 18, theanchors are connected to a tissue repair material 20 in the illustratedunitary surgical devices 10. The tissue repair material 20 in theillustrated embodiments includes: suture; a base; tissue regeneratingmaterial; or combinations of these materials.

In the embodiments of FIGS. 3-10, the tissue repair material 20comprises a fixed length of suture; the suture in the illustratedembodiment has a length of about 4-5 mm. A surgical kit could containseveral unitary surgical devices 10, each with a pair of anchors 16, 18separated by a variety of fixed lengths of suture 20 as the tissuerepair material. The lengths for the sutures portions of the devices 10in the kit could range, for example, from 2 mm to about 1 cm.Alternatively, several kits could be provided each with a plurality ofunitary surgical devices of a particular length. It should be understoodthat these lengths are provided for purposes of illustration only, thepresent invention is not limited to tissue repair material of these orany particular lengths unless expressly called for in the claims. Thesuture used for the tissue repair material 20 in these embodiments maybe standard commercially available suture made of conventionalmaterials. Acceptable suture may be obtained from the sources identifiedabove. FIGS. 3-10 illustrate examples of such unitary surgical devices10 wherein the tissue repair material 20 comprises suture.

Embodiments of the invention utilizing a base 21 as part of the tissuerepair material 20 are illustrated in FIGS.11-23, 25-42, 44-47. The basecomponent 21 of the tissue repair material may comprise a third fixatingmember, such as backstop element 19 shown in FIG. 50. In addition, thebase 21 may provide structural support to the unitary surgical device10. The base may comprise a sheet, as shown in FIGS. 11-23, 25-42, and44-45, and may be a laminar sheet, as illustrated in FIG. 41. The basecomponent may comprise a formed structure, as illustrated in FIG. 42.The formed structures could be laminar or could be formed in othermanners as disclosed below. The base component 21 may also comprise oneor more layers of mesh structures, for example, woven materials asillustrated in FIG. 43, non-woven materials, knitted materials,warp-knitted materials, braided materials, foamed materials andcombinations of those materials; if more than one layer of a meshstructure is provided, the layers may be juxtaposed or spaced, withother material sandwiched between the layers, for example. The basematerial should have sufficient strength so that the connection to theanchors 16, 18 and the connection of the anchors 16, 18 to the patient'snative tissue is maintained during implantation of the unitary surgicaldevice 10 and for a suitable period of time after implantation.Generally, the base 21 should have sufficient strength for a sufficienttime to allow the healing process to progress to the point where thestructural stability provided by the base 21 is no longer needed.However, in the claims no particular strength should be implied theclaims unless expressly recited.

The base 21 in any of the embodiments of FIGS. 11-23, 25-42, 44-47 couldcomprise a biocompatible polymer, a bioremodelable collagenous matrix, anaturally occurring ECM (and in particular SIS) or combinations of thesematerials. The tissue regeneration material 22 may be carried by thebase 21 or may comprise the base 21. The base could also comprise thesematerials together with bioactive agents, other biologically derivedagents, cells, a biological lubricant, or a biocompatible inorganicmaterial. In the claims, no particular material or combination ofmaterials should be implied for the base unless expressly recited.

For a base 21 made out of or including a biocompatible polymer, suitablepolymers are defined above. These polymers can be provided in the formof, for example, meshes of woven or non-woven materials, laminar sheets,knitted materials, warp-knitted materials, braided materials, or one ormore layers of foamed polymer. Reference is also made to the materialsdisclosed in copending U.S. Ser. No. 10/195,341 entitled “HybridBiologic/Synthetic Porous Extracellular Matrix Scaffolds” (AttorneyDocket No. 265280-71144, DEP-751), filed concurrently herewith, alongwith U.S. patent application Ser. No. 10/172,347 entitled “HybridBiologic-Synthetic Bioabsorbable Scaffolds” which was filed on Jun. 14,2002, both of which are incorporated by reference herein in theirentireties.

For a base 21 made out of or including ECM material, several options areavailable. The ECM could comprise material derived from a mammaliansubmucosa source, such as SIS. The ECM base could be formed as alaminate structure, as illustrated in FIG. 41. The layers may belaminated together and bonded by both mechanical compression andapplication of vacuum and/or heated air which accomplishes the bondingand also dries the product. Reference is made to U.S. Pat. No.5,955,110, which is incorporated by reference herein in its entirety,for a description of a method of making layered SIS material. A suitableSIS base may also be formed as described in copending U.S. patentapplication Ser. No. 10/195,794 entitled “Meniscus Regeneration Deviceand Method” (Attorney Docket No. 265280-71141, DEP-745), which isincorporated by reference herein in its entireties. A vacuum plate orplaten with a cavity in a desired shape may be provided, with a vacuumpump connected to the cavity by a tube. The cavity may be provided witha plurality of openings leading to a manifold space within the platenwhich is connected to the pump. Several layers of naturally occurringECM, such as SIS, are placed on the plate. These layers are preferablyinitially in a moist and flexible state. These moist, flexible layersare pulled down into the cavity by the vacuum to form a molded recessfor receiving a mass of biological material. A flat vacuum plate orplaten could also be used to form flat sheet forms of ECM material.These and other techniques may be employed to form the base into adesired shape, such as the wedge shape shown in FIGS. 11-23, 25-26 and30-40.

Other sheet forms of ECM are expected to be useful to provide a base 21or combination base 21 and tissue regeneration material 22. For example,it is anticipated that one could make a thick slurry of comminuted ECMfibers, dry the slurry into a sheet, pocket or other form, such as theform illustrated in FIG. 42, for example, and heat the material undercombinations of pressure, vacuum and heat to bond and dry the product.In addition, one or more such sheets could be laminated together or withstrips of ECM material. It is expected that other shapes and forms couldalso be formed of such materials. It is expected that other materialscould be intermixed with the ECM material as well; for example, thethick slurry could include both ECM material and a biocompatible polymeras a structural reinforcement, or the slurry of ECM material could besupported on and fused with a supporting structure made of ECM or somebiocompatible polymer.

In any of the above examples, the material for the base, such as ECM,can be cross-linked by known methods. For example, chemical or physicalcross-linking can be used. Chemical cross-linking methods include theuse of aldehydes, carbodiimides, glycation agents, enzymes or the like.Physical cross-linking methods include freeze-drying and fusion byphysical means such as heat (thermal cross-linking), radiation(ultraviolet or gamma irradiation) or combinations such as by drying atelevated temperatures (dehydrothermal cross-linking). Cross-linking mayalso be used to impart to the base 21 biological lubricants such ashyaluronic acid (HA).

A portion or all of the base 21 may be perforated to allow easy chemicaland cellular transfer. In addition, if desired, cells, bioactive agents,biologically derived agents, biological lubricants and biocompatibleinorganic materials may be added to the base.

The base 21 may also include a foamed or hybrid structure, and mayinclude other materials as disclosed in applications for United StatesPatent filed concurrently herewith and previously filed, which areincorporated by reference herein in their entireties: U.S. patentapplication Ser. No. 10/172,347 entitled “Hybrid Biologic-SyntheticBioabsorbable Scaffolds” which was filed on Jun. 14, 2002; Ser. No.10/195,341 entitled “Hybrid Biologic/Synthetic Porous ExtracellularMatrix Scaffolds” (Attorney Docket No. 265280-71144, DEP-751) filedherewith; Ser. No. 10/195,606 entitled “Cartilage Repair andRegeneration Device and Method” (Attorney Docket No. 265280-71145,DEP-752) filed herewith; and Ser. No. 10/195,354 entitled “PorousExtracellular Matrix Scaffold and Method” (Attorney Docket No.265280-71146, DEP-747) filed herewith.

The base 21 may take any one of several shapes and configurations. Forexample, as illustrated in FIGS. 27-29, the base 21 may comprise asingle substantially flat panel. As illustrated in FIGS. 10-23, 25-26and 30-40, the base 21 may comprise two integral panels 24, 26 joinedalong a linear or curved apex 28; the two illustrated panels 24, 25diverge outward from the apex 28 to define a wedge-shaped or V-shapedstructure in cross-section. The side edges 30, 32 of each panel 24, 26may also diverge outwardly from the apex 28, as shown in FIGS. 13, 18,22-23 and 30. The base 21 may comprise a pillow-like structure, like asac made of the base material, with a mass of tissue regenerationmaterial held within the sac or pillow structure.

In each of the embodiments of FIGS. 11-23, 25-40,42 and 44-45, a mass oftissue regeneration material 22, such as ECM, is included as part of thetissue repair material 20. In each of these embodiments, the mass oftissue regeneration material 22 comprises a separate mass that issecured to the base 21. In the embodiment of FIG. 44, a plurality(three) of masses of tissue regeneration material 22 are fixed to thebase 21. In the embodiments of FIGS. 11-23, 25-26 and 30-40, a singlemass of tissue regeneration material 22 is positioned between the twopanels 24, 26 near the apex 28; the masses of tissue regenerationmaterial 22 in these illustrated embodiments are wedge-shaped orV-shaped in cross-section, although it should be understood that othershapes are within the scope of the invention. As illustrated in FIG. 42,the mass of tissue regeneration material could also comprise a loosepack of comminuted or shredded ECM material. As disclosed in U.S.Provisional Patent Application Ser. No. 60/305,786, the SIS materialcould comprise rolls of comminuted SIS. It should also be understoodthat, depending on the material used for the base 21, the unitarysurgical device need not include any additional tissue regenerationmaterial; for example, if the base 21 comprises one or more layers ofECM mesh or an ECM foam, then it may not be necessary to include aseparate mass of tissue regeneration material.

If a separate mass of tissue regeneration material 22 is used, it may besecured to the base 21 by use of a compatible adhesive. Syntheticadhesives are commercially available, such as polycaprolactone (PCL.Biological adhesives are also available, such as commercially availablematerials containing transglutaminase or fibrin, for example. Otherbiological adhesives are also known, as described in U.S. Pat. No.6,326,025 “Tissue Reactive Adhesive Compositions” and in published U.S.Pat. Apps. 200200344533 “Bioerodable Polymeric Adhesives for TissueRepair” and 20020031551 “Bioerodable Polymeric Adhesives for TissueRepair.” The adhesive can be applied to the tissue regeneration material22 and to the base 21. The tissue regeneration material 22 may besecured to a pillow or sac-like base by substantially enclosing the massof tissue regeneration material within the base structure, such as bysuturing three or four sides of the base structure around the mass oftissue regeneration material, by using a compatible adhesive around theperimeter of the base surrounding the mass of tissue regenerationmaterial. The tissue regeneration material may also be secured to thebase by positioning the tissue regeneration material in a formedreceiving structure or pocket, as in the embodiment of FIG. 42. Inaddition, layers of SIS material could be laminated around all or partof the mass of tissue regeneration material. Chemical and physicalcross-linking may also be used to secure the mass of tissue regenerationmaterial 22 to the base 21. Chemical cross-linking methods of securingthese materials 21, 22 together include the use of aldehydes,carbodiimides, glycation agents, enzymes (e.g., transglutaminase),biologics (e.g., fibrin) or the like. Physical cross-linking methodsinclude freeze-drying and fusion by physical means such as heat (thermalcross-linking), radiation (ultraviolet or gamma irradiation) orcombinations such as by drying at elevated temperatures (dehydrothermalcross-linking).

The mass or plug of tissue regeneration material 22 may comprisecomminuted and/or lyophilized naturally occurring ECM (e.g., SIS) withthe desired porosity and material density. The material density and/orporosity of the mass or plug may be varied to control cell migration andproliferation. Additional examples of materials that are usable for themass of tissue regeneration material include ECM (e.g., SIS) powder, ECM(e.g., SIS) fibers, ECM (e.g., SIS) threads, ECM (e.g., SIS) mesh, ECM(e.g., SIS) wovens, ECM (e.g., SIS) non-wovens, ECM (e.g., SIS) braidedmaterials, ECM (e.g., SIS) solutions, ECM (e.g., SIS) gel, ECM (e.g.,SIS) paste, ECM (e.g., SIS) foam, and combinations of such materials.For the powder, solutions, gel and paste forms of SIS, the material maybe prepared as described in U.S. Pat. No. 5,352,463, entitled “TissueGraft for Surgical Reconstruction of a Collagenous Meniscus and MethodTherefor”, which is incorporated by reference herein in its entirety. Itshould be understood that separate reference in the above list to theforms of ECM should not be taken to imply that the listed references areexclusive; for example, ECM non-wovens, ECM threads and ECM foam may allinclude ECM fibers.

The mass or plug of tissue regeneration material 22, and the base 21, orthe combination of the base and the tissue regeneration material mayinclude materials described in U.S. Pat. No. 6,179,872 B1, entitled“Biopolymer Matt for Use in Tissue Repair and Reconstruction” and U.S.Pat. No. 6,153,292, entitled “Biopolymer Foams for Use in Tissue Repairand Reconstruction”, which are both incorporated by reference herein intheir entireties. The mass or plug of tissue regeneration material 22and the base, or the combination of the base and the tissue regenerationmaterial may include materials disclosed in the following copending andconcurrently filed U.S. patent applications, which are incorporated byreference herein: Ser. No. 10/195,794 entitled “Meniscus RegenerationDevice and Method” (Attorney Docket No. 265280-71141, DEP-745); Ser. No.10/195,719 entitled “Devices from Naturally Occurring BiologicallyDerived Materials” (Attorney Docket No. 265280-71142, DEP-748); Ser. No.10/195,347 entitled “Cartilage Repair Apparatus and Method” (AttorneyDocket No. 265280-71143, DEP-749); Ser. No. 10/195,341 entitled “HybridBiologic/Synthetic Porous Extracellular Matrix Scaffolds” (AttorneyDocket No. 265280-71144, DEP-751); Ser. No. 10/195,606 entitled“Cartilage Repair and Regeneration Device and Method” (Attorney DocketNo. 265280-71145, DEP-752); Ser. No. 10/195,354 entitled “PorousExtracellular Matrix Scaffold and Method” (Attorney Docket No.265280-71146, DEP-747); Ser. No. 10/195,334 entitled “Cartilage Repairand Regeneration Scaffolds and Method” (Attorney Docket No.265280-71180, DEP-763); and Ser. No. 10/195,633 entitled “PorousDelivery Scaffold and Method” (Attorney Docket No. 265280-71207,DEP-762), along with U.S. patent application Ser. No. 10/172,347entitled “Hybrid Biologic-Synthetic Bioabsorbable Scaffolds” which wasfiled on Jun. 14, 2002.

The mass of plug of tissue regeneration material 22 could also compriseother collagenous materials. For example, it is expected that acommercial product such as the Collagen Meniscus Implant made by ReGenBiologics, Inc. of Franklin Lakes, N.J. could be combined with otherelements of the present invention to form a unitary surgical device.Other collagen scaffolds are described in the following U.S. Pat. Nos.6,042,610; 5,735,903; 5,479,033; 5,306,311; 5,007,934; and 4,880,429.

Porous ECM (e.g., SIS) foam for the tissue regeneration material 22 maybe fabricated by lyophilizing (i.e., freeze-drying) comminuted ECM(e.g., SIS) suspended in water. The material density and pore size ofthe resultant foam may be varied to fit the needs of the design bycontrolling, amongst other things, the rate of freezing of thecomminuted ECM suspension and/or the amount of water in which thecomminuted ECM is suspended at the on-set of the freezing process.

The following is a specific example of a process for fabricating anexemplary ECM foam. It should be understood that the present inventionis not limited to the materials, devices, or process steps of thefollowing example unless expressly called for in the claims. The firststep in developing a foam with a desired pore size and density is theprocurement of comminuted ECM. To do this, scissor-cut ECM runners(e.g., SIS runners about 6 inches long) are positioned in a 1700 seriesComitrol™ machine which is commercially available from UrschelLaboratories of Valparaiso, Ind. The ECM material is processed andthereafter collected in a receptacle at the output of the machine. Thematerial is then processed through the machine a second time undersimilar conditions. Water is introduced during the process, and theresultant material is a “slurry” of ECM fiber (thin, long fibers about200 microns thick×1-5 mm long) suspended substantially uniformly inwater. It should be understood that this size of ECM fiber is identifiedas an illustrative example only; the invention is not limited to aparticular size of ECM fiber material unless the claims expressly callfor a particular size.

Generally, the process parameters for the comminution process should beselected to produce ECM material that is capable of commingling,intermixing or intertwining, rather than producing a powder. Processparameters that can be varied using the above-identified 1700 seriesComitrol™ machine include the choice of blade used, whether water isused, the amount of water used, the speed at which the blades turn andthe number of times the material is passed through the machine. As anexample, cutting head 140084-10 and a Vericut, sealed impeller fromUrschel Laboratories may be used, with a flow of water of about two (2)gallons per minute, with the cutting head run at a constant speed ofabout 9300 rpm. A first pass through the machine at these parameterswill produce fibrous ECM material of varying sizes, and a second passwill produce ECM fibers of more uniform size. To test the comminutedmaterial to determine whether it is appropriate for the production of anECM foam, the comminuted ECM suspension or slurry is then centrifuged,excess water is poured off and the remaining slurry is poured into adish. By hand, a small amount of the comminuted ECM material in the dishis pinched between the thumb and index finger and gently lifted from thedish; if the comminuted SIS material is fibrous, at least a small amountof additional ECM, beyond the portion pinched between the thumb andindex finger, will lift along with the material that has been pinched.This additional comminuted ECM material lifts with the material that isbetween the thumb and index finger because the individual pieces ofcomminuted ECM material are commingled or intertwined. Such materialshould be suitable for the production of a foam. It is expected thatother shapes and sizes of ECM material, and mixtures of shapes and sizesof ECM material, may be useful in producing an ECM foam. For example, itis expected that one could comminute ECM to produce ECM flakes that canintermingle to form an appropriate slurry.

As used herein, unless the claims are otherwise expressly limited, theterms “cohesive ECM pieces” and “cohesive SIS pieces” are intended toinclude ECM and SIS material that has been comminuted or otherwiseprocessed to produce ECM and SIS pieces that are capable of comminglingor intertwining (in the wet or dry state) to form a cohesive mass ofdiscrete elements, regardless of the shape or shapes of the individualECM or SIS pieces. One method of demonstrating that the ECM materialcomprises cohesive pieces is the “pinch test” described above.Examination of the final ECM foam product produced may also provideevidence that the base material comprised cohesive ECM pieces.

As used herein, “pieces” is intended to include any fiber, strip,ribbon, sliver, filament, shred, bit, fragment, part, flake, slice, cut,chunk, or other portion of solid or solid-like material. “ECM fiber” and“SIS fiber” are also intended to include ECM and SIS material that hasbeen comminuted or otherwise processed to produce a material wherein atleast some of the individual pieces of ECM and SIS material have lengthsgreater than their widths and thicknesses. It should be understood thatunless otherwise expressly limited by the claims, use of the terms “ECMpieces” and “SIS pieces” should be construed to mean that the materialincludes such pieces, but should not be considered to imply that thematerial consists of such pieces exclusively. Such terms should also notbe construed to imply that any particular process has been used toproduce the material.

After the suspension has been formed, the suspension of SIS fibers isdried. To do so, a lyophilization process (freeze drying) is used. Inparticular, the suspension of SIS fibers is frozen at a controlledtemperature drop rate to control the size of the formed ice crystals.Without allowing the material to thaw, the process of lyophilizationsublimes ice crystals directly to vapor under vacuum and lowtemperatures. This process leaves voids in the spaces previouslyoccupied by ice crystals. These voids and the SIS fibrous material forma network of compartments with SIS material defining interconnectedwalls of the network compartments. One exemplary machine for performingsuch a freeze drying process is a Virtis Genesis™ Series lyophilizerwhich is commercially available from SP Industries, Inc. of Gardiner,N.Y.

The process parameters of the lyophilization process may be varied toproduce foams of varying pore sizes and material densities. For example,to produce foams having a relatively small pore size and a relative highmaterial density, the SIS fibrous material may be tightly compacted byremoving the water in a substantially uniform manner so as to achieve arelatively high density. Thereafter, the SIS fibrous material isflash-frozen using liquid nitrogen prior to lyophilization of the SIS.To produce foams having a moderate pore size and a moderate materialdensity, the SIS fibrous material is first tightly compacted by removingthe water in a substantially uniform matter so as to achieve arelatively high density. Thereafter, the SIS is frozen at a relativelyfast rate (e.g., >−1° C./min.) to a temperature of about −80° C. priorto lyophilization of the SIS.

As shown in the photomicrographs (FIGS. 1-3) in co-pending U.S. patentapplication Ser. No. 10/195,354 entitled “Porous Extracellular MatrixScaffold and Method” (Attorney Docket No. 265280-71146, DEP-747), filedby Prasanna Malaviya, Herbert Schwartz and Pamela Plouhar, the result ofusing the above-described process and materials is an ECM foamcomprising a three-dimensional web of naturally occurring ECM defining aplurality of three-dimensional pores. The foam has three-dimensionalpores throughout its height, width and thickness; the three-dimensionalpores are interconnected to define a plurality of interconnectedpassageways. These interconnected passageways may be used for movementof cells such as chondrocytes in vivo. These interconnected passagewayscan also be used for the introduction of bioactive agents, biologicallyderived agents (e.g., stimulants), cells, biocompatible inorganicmaterials, biocompatible polymers and/or biological lubricants that maybe combined with the foam as described below prior to implantation. Theinterconnected passageways defined by the three-dimensional pores alsoserve as passageways for materials used during the manufacturingprocess, such as compounds used for chemical cross-linking the foam.

The tissue regeneration material 22 may be chemically cross-linked with,for example, aldehydes, carbodiimides, glycation agents, enzymes (e.g.,transglutaminase), biologics (e.g., fibrin) or the like. The tissueregeneration material 22 may also be physically cross-linked, by, forexample: freeze-drying, heat fusion (thermal cross-linking), radiationfusion (ultraviolet or gamma irradiation) or combinations of fusiontechniques such as by drying at elevated temperatures (dehydrothermalcross-linking).

The base 21 and/or the mass of tissue regeneration material 22 may alsobe impregnated with bioactive agents, biologically derived agents,cells, biocompatible polymers, biocompatible inorganic materials andbiological lubricants. The materials could be cross-linked or otherwiseaffixed to the ECM base and/or mass. Alternatively, cells (e.g.,fibrochondrocytes) may be cultured on the ECM base and/or mass, and as aresult, subsequently be implanted as part of the unitary surgical deviceat the time of implantation. For the meniscus repair device, any suchcells are preferably fibrochondrocytes or mesenchymal stem cells.

“Bioactive agents” include one or more of the following: chemotacticagents; therapeutic agents (e.g., antibiotics, steroidal andnon-steroidal analgesics and anti-inflammatories, anti-rejection agentssuch as imnmunosuppressants and anti-cancer drugs); various proteins(e.g., short chain peptides, bone morphogenic proteins, glycoprotein andlipoprotein); cell attachment mediators; biologically active ligands;integrin binding sequence; ligands; various growth and/ordifferentiation agents (e.g., epidermal growth factor, IGF-I, IGF-II,TGF-β I-III, growth and differentiation factors, vascular endothelialgrowth factors, fibroblast growth factors, platelet derived growthfactors, insulin derived growth factor and transforming growth factors,parathyroid hormone, parathyroid hormone related peptide, bFGF; TGF_(β)superfamily factors; BMP-2; BMP4; BMP-6; BMP-12; sonic hedgehog; GDF5;GDF6; GDF8; PDGF); small molecules that affect the upregulation ofspecific growth factors; tenascin-C; hyaluronic acid; chondroitinsulfate; fibronectin; decorin; thromboelastin; thrombin-derivedpeptides; heparin-binding domains; heparin; heparan sulfate; DNAfragments and DNA plasmids. If other such substances have therapeuticvalue in the orthopaedic field, it is anticipated that at least some ofthese substances will have use in the present invention, and suchsubstances should be included in the meaning of “bioactive agent” and“bioactive agents” unless expressly limited otherwise. It should beunderstood that the above agents are identified by way of example only,and the present invention is not limited to any particular agent unlessexpressly called for in the claims.

“Biologically derived agents” include one or more of the following: bone(autograft, allograft, and xenograft) and derivates of bone; cartilage(autograft, allograft and xenograft), including, for example, meniscaltissue, and derivatives; ligament (autograft, allograft and xenograft)and derivatives; derivatives of intestinal tissue (autograft, allograftand xenograft), including for example submucosa; derivatives of stornach tissue (autograft, allograft and xenograft), including for examplesubmucosa; derivatives of bladder tissue (autograft, allograft andxenograft), including for example submucosa; derivatives of alimentarytissue (autograft, allograft and xenograft), including for examplesubmucosa; derivatives of respiratory tissue (autograft, allograft andxenograft), including for example submucosa; derivatives of genitaltissue (autograft, allograft and xenograft), including for examplesubmucosa; derivatives of liver tissue (autograft, allograft andxenograft), including for example liver basement membrane; derivativesof skin (autograft, allograft and xenograft); platelet rich plasma(PRP), platelet poor plasma, bone marrow aspirate, demineralized bonematrix, insulin derived growth factor, whole blood, fibrin and bloodclot. Purified ECM and other collagen sources are also intended to beincluded within “biologically derived agents.” If other such substanceshave therapeutic value in the orthopaedic field, it is anticipated thatat least some of these substances will have use in the presentinvention, and such substances should be included in the meaning of“biologically derived agent” and “biologically derived agents” unlessexpressly limited otherwise. It should be understood that the aboveagents are identified by way of example only, and the present inventionis not limited to any particular agent unless expressly called for inthe claims.

“Cells” include one or more of the following: chondrocytes;fibrochondrocytes; osteocytes; ostoeblasts; osteoclasts; synoviocytes;bone marrow cells; mesenchymal cells; stromal cells; stem cells;embryonic stem cells; precursor cells derived from adipose tissue;peripheral blood progenitor cells; stem cells isolated from adulttissue; genetically transformed cells; a combination of chondrocytes andother cells; a combination of osteocytes and other cells; a combinationof synoviocytes and other cells; a combination of bone marrow cells andother cells; a combination of mesenchymal cells and other cells; acombination of stromal cells and other cells; a combination of stemcells and other cells; a combination of embryonic stem cells and othercells; a combination of precursor cells isolated from adult tissue andother cells; a combination of peripheral blood progenitor cells andother cells; a combination of stem cells isolated from adult tissue andother cells; and a combination of genetically transformed cells andother cells. If other cells are found to have therapeutic value in theorthopaedic field, it is anticipated that at least some of these cellswill have use in the present invention, and such cells should beincluded within the meaning of “cell” and “cells” unless expresslylimited otherwise. It should be understood that the above cells areidentified by way of example only, and the present invention is notlimited to any particular type of cell unless expressly called for inthe claims.

“Biological lubricants” include: hyaluronic acid and its salts, such assodium hyaluronate; glycosaminoglycans such as dermatan sulfate, heparansulfate, chondroitin sulfate and keratan sulfate; synovial fluid andcomponents of synovial fluid, including mucinous glycoproteins (e.g.,lubricin), tribonectins, articular cartilage superficial zone proteins,surface-active phospholipids, lubricating glycoproteins I, II;vitronectin; and rooster comb hyaluronate. “Biological lubricant” isalso intended to include commercial products such as ARTHEASE™ highmolecular weight sodium hyaluronate, available in Europe from DePuyInternational, Ltd. of Leeds, England, and manufactured byBio-Technology General (Israel) Ltd., of Rehovot, Israel; SYNVISC® HylanG-F 20, manufactured by Biomatrix, Inc., of Ridgefield, N.J. anddistributed by Wyeth-Ayerst Pharmaceuticals of Philadelphia, Pa.;HYLAGAN® sodium hyaluronate, available from Sanofi-Synthelabo, Inc., ofNew York, N.Y., manufactured by FIDIA S.p.A., of Padua, Italy; andHEALON® sodium hyaluronate, available from Pharmacia Corporation ofPeapack, N.J. in concentrations of 1%, 1.4% and 2.3% (for ophthalmologicuses). If other such substances have therapeutic value in theorthopaedic field, it is anticipated that at least some of thesesubstances will have use in the present invention, and such substancesshould be included in the meaning of “biological lubricant” and“biological lubricants” unless expressly limited otherwise. In addition,as new biological lubricants are identified or developed, it is expectedthat at least some of them will be useful materials for the presentinvention. It should be understood that the above materials areidentified by way of example only, and the present invention is notlimited to any particular material unless expressly called for in theclaims.

“Biocompatible inorganic materials” include materials such ashydroxyapatite, all calcium phosphates, alpha-tricalcium phosphate,beta-tricalcium phosphate, calcium carbonate, barium carbonate, calciumsulfate, barium sulfate, polymorphs of calcium phosphates, ceramicparticles and combinations of such materials. If other such substanceshave therapeutic value in the orthopaedic field, it is anticipated thatat least some of these substances will have use in the presentinvention, and such substances should be included in the meaning of“biocompatible inorganic material” and “biocompatible inorganicmaterials” unless expressly limited otherwise.

It is expected that various combinations of bioactive agents,biologically derived agents, cells, biological lubricants, biocompatibleinorganic materials, biocompatible polymers can be used with theanchors, bases, and tissue repair material (including tissueregeneration material) of the present invention.

The unitary surgical devices 10 of FIGS. 11-23, 27-40 and 42 may besized to fit the standard gap 70 left in the meniscus by a meniscectomyso that one unitary surgical device can be implanted to fill this gap70. It may be desirable to make a plurality of sizes of such unitarysurgical devices 10 to encompass the standard range of gaps 70 left bymeniscectorn ies. In addition, it may be desirable to plan to be able touse more than one unitary surgical device 10 to fill the gap 70 left bythe meniscectomy, so that a plurality of unitary surgical devices 10 maybe implanted adjacent to or overlapping with one another to fill the gap70 during the surgery.

To make a unitary surgical device 10 that includes two anchors 16, 18connected by a length of suture as the tissue repair material 20, theanchors may be formed as described above. The anchors 16 a-16 g, 18 a-18g may be formed to include, or machined to include an opening so thatone end of each length of suture may be secured to one anchor. Forexample, the anchors 16, 18 could be tubular so that one end of suturecan be threaded through each anchor and then knotted to secure themtogether. Or, the anchors could have a hole through which the suture endis threaded and then knotted.

To make a unitary surgical device 10 that includes both a laminar baseand suture, as in the embodiments of FIGS. 22-23, 25-26 and 30-31,threads of suture 34 may be placed between two layers of base materialprior to completely forming the base so that the suture threads 34become integral with the base 21 during the forming process. Asillustrated, the lengths of the suture threads 34 should be great enoughso that the suture ends extend substantially beyond the parallel endedges 36, 38 of the unitary surgical device to define the first fixatingelement 15 and second fixating element 17 at the opposite ends of thesuture thread 34. As illustrated, a plurality of suture threads may bemade integral with each base. In the embodiments of FIGS. 22-23 and30-31, three long strands of suture 34 are used, so that the resultingunitary surgical device has a total of six fixating elements: the firstfixating element 15, the second fixating element 17, a third fixatingelement 40, a fourth fixating element 42, a fifth fixating element 44,and a sixth fixating element 46. The three suture threads 34 for thisembodiment may be aligned so that one length of suture is positionedalong the longitudinal centerline of the base, and additional lengths ofsuture are positioned between the longitudinally aligned thread and thelong edges 30, 32 of the base 21, and aligned with the shape of the longedges 30, 32 of the base 21. The laminar base 21 may then be made asdescribed in the provisional application with each suture thread 34 inplace between two layers. The finished unitary surgical device 10 willinclude the suture affixed to the base. The base 21 of FIG. 22 may thenbe folded about axis 48 to form the wedge-shaped structure shown in FIG.23, with the linear apex 28 at the axis 48. If desired, additionalanchors such as barbs, tacks, or backstops, for example, could besecured to the free ends of the suture, as illustrated in the embodimentof FIGS. 30-31. It should be understood that fewer or more strands ofsuture may be used for the devices illustrated in FIGS. 22-23 and 30-31;for example, two strands of suture could be used, or four strands ofsuture could be used.

For non-laminar bases, the suture threads 34 could be positioned in oron the base material prior to final forming of the base. The base maythen be formed as described above with the suture formed as an integralpart of the base. In any case, suture could also be adhered to the baseor could be sewn to the base.

To make the embodiments of FIGS. 34-38, an anchor such as a barb may bepositioned on the surface of base laminates, as shown in FIG. 41, whereanchor 16 b is shown on layers 23 i-23 l of laminate. Then, additionallayers, such as layers 23 a-23 h shown in FIG. 41, may be placed on theinitial base laminate 23 i-23 l, surrounding part of the anchor 16 b.The unitary surgical device may then be formed with the anchor 16 bbecoming secured to at least some of the layers of the base as thelayers are dried, heated and compressed. Other forms of anchor can bepositioned on the base during fabrication of the base so that completionof the base also secures the anchors to the base to form a unitarystructure.

Any of the anchors could also be secured to the base after the base isformed by, for example, using an adhesive to secure the anchor to thebase. Suitable adhesives for this purpose include commercially availablematerials such as those containing fibrin or transglutaminase. It shouldbe understood that other methods for securing the anchors to the baseare within the scope of this invention; the invention is not limited toany particular method of securing the elements together unless expresslycalled for in the claims.

All of the illustrated embodiments of the invention may be prepared foruse in surgery by providing prepackaged unitary surgical devices orkits. Thus, for example, after making any of the illustrated embodimentsof unitary surgical device, a single unitary surgical device can bepackaged and terminally sterilized, so that the surgeon may simply openthe package and implant the device. It may be desirable to prepackage akit including several unitary surgical devices of different sizes. Asdiscussed above, for the embodiments of FIGS. 3-10, a kit could includeseveral unitary surgical devices 10, each with a pair of anchors 16, 18separated by a variety of fixed lengths of suture 20 as the tissuerepair material. For the embodiments of FIGS. 11-23, 25-40,42 and 44-45,53, each device could be made in a plurality of sizes, such as small,medium and large; a kit could comprise a group of unitary surgicaldevices of all sizes or a group of unitary surgical devices all of onesize, for example. Conventional commercially available packagingmaterials and sterilization techniques can be used. For example, gammairradiation or electron beam irradiation can be used for this terminalsterilization. It should be understood however, that the presentinvention is not limited to any particular packaging material orsterilization technique unless expressly called for in the claims.

If any of the embodiments are to be seeded with living cells such aschondrocytes, the terminally sterilized implant can subsequently beseeded with living cells and packaged in an appropriate medium for thecell type used. For example, a cell culture medium comprising Dulbecco'sModified Eagles Medium (DMEM) can be used with standard additives suchas non-essential aminoacids, glucose, ascorbic acid, sodium pyrovate,fungicides, antibiotics, etc., in concentrations deemed appropriate forcell type, shipping conditions, etc.

Use of the illustrated embodiments of the invention is described below.All of the embodiments of the present invention may be used in surgicalrepair of a damaged meniscus 12, as illustrated in FIGS. 1-2, where themeniscal injury is illustrated as a meniscal tear 14 extending down fromthe top bearing surface 50 of the meniscus 12 between the inner arcuateedge 52 of the meniscus 12 and the back or outer arcuate surface 54 ofthe meniscus 12. It should be understood that the drawings show themeniscus 12 in simplified form for purposes of illustration only.

The first group of illustrated unitary surgical repair devices,illustrated in FIGS. 4-10, are useful for surgical meniscal repairs.With each of these devices, the objective is the same: to position theanchors 16, 18 beyond the tear 14, and to position the tissue repairmaterial 20, comprising suture in the embodiments of FIGS. 4-10, acrossthe tear 14. For each of these embodiments, a surgical kit wouldgenerally be provided with several unitary surgical devices 10, withvarying lengths of suture, provided in the kit. The meniscal tear isevaluated and the meniscus is prepared in the standard manner. From theinitial evaluation, the surgeon determines the length of device that isneeded to extend across the meniscal injury for the particular patient,and then selects one of the devices from the surgical kit. Using theembodiments illustrated in FIGS. 4 and 8, at least one of the anchors,such as first anchor 16, is positioned within the meniscus 12, while thesecond anchor 18 is positioned on the back arcuate surface 54 of themeniscus, with the suture 20 connecting the anchors and extending acrossthe tear 14. The first anchor 16 is pushed far enough into the meniscusto approximate the two inner surfaces 56, 58 of the meniscal tear 14.The shapes of the anchors 16, 18 hold their final position. Neitheranchor is exposed on a bearing surface of the meniscus. For theembodiments of FIGS. 4 and 8, preferably the anchor 18 that bearsagainst the back non-bearing surface 54 of the meniscus is positionedfirst, and then the anchor 16 that extends into the interior of themeniscus is positioned. A tubular needle such as that used with theRAPIDLOC™ Meniscal Repair System could be employed. Such a device couldhave a cable or similar structure running through the needle andconnected to a trigger or similar device to selectively implant one ofthe anchors. The surgeon could insert the needle through the toparticular surface 50 of the meniscus, and push the needle through thebody of the meniscus until reaching the back surface 54. The trigger maythen be operated to release one of the anchors, such as anchor 18 inFIG. 4, against the back surface 54 of the meniscus. At this stage, alength of suture 20 extends out of the top surface 50 of the meniscusand extends to the other anchor 16. The surgeon may then use a pair offorceps of similar device and push the anchor 16 through the top surface50 and into the body of the meniscus until the two surface 56, 58 at thetear are approximated. Both anchors 16, 18 should then stay in place,holding the meniscus as shown in FIG. 4 so that the meniscus can heal.Similar surgical procedures may be used to implant the embodiments ofthe unitary surgical devices 10 illustrated in FIGS. 6 and 10. It shouldbe understood that this surgical technique is provided by way of exampleonly, and that the present invention is not limited to any particularsurgical technique unless expressly called for in the claims. Additionalunitary surgical devices 10 can be implanted until all the tissuesurfaces are adequately approximated and the tear is stabilized.

In some instances, it may be desirable to facilitate healing of the tornmeniscus by using a unitary surgical device 10 of the type shown inFIGS. 44 and 45. With these embodiments of the invention, the base 21and tissue regeneration material 22 are thin, and nearly planar in crosssection. The anchoring devices 16, 18 are used for delivering theunitary surgical device to the proper location in the meniscal tear 14,between the two inner surfaces 54, 56 of the meniscal tear 14. Withthese devices, the first anchor 16, or first and second anchors 16, 18,are inserted on the end of one or two needles (not shown), and theneedles are pushed through the inner surface 58 of the meniscal tear 14and through the body of the meniscus and out through the back side 54 ofthe meniscus 12. The anchoring device or devices 16, 18 are movedthrough the back 54 of the meniscus until one of the faces 60 of theunitary surgical device 10 is juxtaposed with the inner surface 58 ofthe meniscal tear 14, as shown in FIGS. 46 and 47. The remaining sutureat the back of the meniscus may be cut off, removed and discarded. Oncethe unitary surgical device 10 is in place in the meniscal tear 14 asshown in FIGS. 46-47, the surgeon may then approximate the meniscalinner surface 56 and the opposite face 62 of the base 21 of the unitarysurgical device 10, and secure the parts in this position using sutureor another unitary surgical device, such as one of the devices of FIGS.4-10. FIGS. 48 and 49 illustrate the meniscus with the tear 14approximated to the implanted unitary surgical device 10. In FIG. 48,the surfaces of the meniscus and the implanted unitary surgical deviceare secured together with suture, shown at 64, while in FIG. 49, thesurfaces are secured together with another unitary surgical device 10 ofthe type shown in FIG. 4.

Instruments that may be used in delivering the unitary surgical devicesof FIG. 45 may include a Meniscal Applier (REF 228000) available fromthe Mitek Products division of Ethicon, Inc., of Westwood, Mass. TheMitek Meniscal Applier may be modified to provide a greater curvature ifdesired. 90° mosquito forceps may also be used to implant the unitarysurgical devices.

If the injury or damage to the meniscus 12 is so severe that ameniscectomy or partial meniscectomy is necessary, the surgeon mayremove a portion of the meniscus as illustrated in FIGS. 15 and 24.Generally, the surgeon will remove the damaged or diseased tissue, asshown in FIGS. 15 and 24, leaving a generally wedge-shaped void 70. Itshould be understood that the illustrations in FIGS. 15 and 24 aresimplified for purposes of illustration; the actual area of removedtissue may look different from that illustrated. The portion of themeniscus that is removed is from the inner arcuate edge 52 of themeniscus to a position inward of the back arcuate surface 54 of themeniscus, so that an arcuate portion of the back 54 of the meniscusremains after the meniscectomy. This back portion to the meniscus, shownat 72 in FIGS. 15-17, 19, 21, 24-26, 29, 31, 33, 36, 38 and 40. Althoughthe meniscectomy can extend to the highly vascularized red zone of themeniscus, the back portion 72 can include more than red zone tissue.

With part of the meniscus 12 removed, the surgeon may opt to use one ofthe embodiments of the unitary surgical device 10 illustrated in FIGS.11-23, 25-40 and 42. Considering each embodiment in order, the unitarysurgical device 10 of the FIG. 11 embodiment is wedge shaped incross-section, and may be placed so that the tissue regenerationmaterial and the base 21 fit within the void 70 left after part of themeniscus has been removed. The first and second anchors 16, 18 comprisetwo lengths of suture secured to a disc 73 of biocompatible andbioabsorbable material. The first and second anchoring sutures extendthrough a part of the tissue regeneration material 22, and out throughthe lower face of the base 21. These anchoring sutures 16, 18 may bepushed through the back portion 72 of the meniscus as shown in FIG. 12,and pulled tight until the back surface 74 of the device 10 isjuxtaposed with the front surface 76 of the back portion 72 of themeniscus. The ends of the two anchoring sutures 16, 18 may then be tiedagainst the back surface 54 of the meniscus 12 as shown in FIG. 12.

In the embodiment of FIG. 13, the base 21 is somewhat larger than thewedge of tissue regeneration material 22, extending rearward of the backsurface 74 of the tissue regeneration material 22 and forming upper andlower projections 80, 82 as shown in FIG. 14. In this embodiment, thefirst and second anchoring sutures 16, 18 comprise a length of sutureextending substantially across one dimension of the base 21 at the backof the base, and out through holes 78 in the base 21. The two anchorsutures 16, 18 may be inserted with a needle or similar device (notshown) through the front surface 76 of the back red portion 72 of themeniscus, or through the bottom surface of the body of the meniscus. Thetwo anchoring sutures 16, 18 may be pushed through the body of themeniscus and through the arcuate back surface 54, where they may be tiedoff, as shown in FIG. 17. As shown in FIGS. 16-17, the unitary surgicaldevice substantially fills the void 70 left by the meniscectomy. Asshown in FIG. 17, the front surface 76 of the vascularized portion 72 ofthe meniscus abuts the back surface 74 of the tissue regenerationmaterial 22 so that the blood vessels may deliver cells and othermaterials to the tissue regeneration material 22 for the healingprocess.

The anchoring sutures 16, 18 may also be along the top of the base 21,as shown in the embodiment of FIGS. 18-19, and the upper projection 80may be greater than the lower projection 82. It should be understoodthat the lower projection could also be made to be greater than theupper projection 80.

As shown in FIGS. 20-21, the anchoring sutures 16, 18 can also beconnected directly to the back surface 74 of the mass of tissueregeneration material 22. To make such a unitary surgical device 10,these anchoring sutures 16, 18 could be positioned prior to finalforming of the tissue regeneration material, adhered to the tissueregeneration material or mechanically attached to the tissueregeneration material, such as by sewing the suture to the tissueregeneration material; any of these methods of securing the anchors 16,18 to the tissue regeneration material 22 would be performed prior toimplantation of the unitary surgical device. Also as shown in FIG. 20,the top portion of the base 21 need not be secured to the mass of tissueregeneration material 22, the top portion of the base 21 could insteadbe sutured to the back vascularized portion 72 of the meniscus, as shownat 86 in FIG. 21.

As shown in the embodiment of FIGS. 22-23, 25 and 26, a plurality ofanchors 16, 18, 40, 42, 44, 46 may be provided. As shown in FIGS. 25-26,the unitary surgical device 10 of FIGS. 22-23 may be implanted byextending one group of sutures 16, 40, 44 over the top of thevascularized portion 72 of the meniscus, one group of sutures 18, 42, 46under the vascularized portion 72 of the meniscus, and moving theunitary surgical device toward the vascularized portion 72, so that theunitary surgical device 10 fills the void 70 in the meniscus. All of thesutures 16, 18, 40, 42, 44, 46 may than be anchored to the back surface54 of the vascularized portion of the meniscus as shown in FIG. 26. Ascan be seen from FIG. 26, in this embodiment the upper projection 80 andunder projection 82 both cover the portion of the upper surface 50between the surfaces 76 and 54 and the portion of the lower surface 88of the meniscus between the surfaces 76 and 54.

As shown in the embodiment of FIGS. 28-29, the unitary surgical device10 need not be wedge shaped. The base 21 could comprise a flat sheetwith a pillow or other mass of tissue regeneration material 22 shaped tofill the void 70 left by the meniscectomy. The unitary surgical device10 may then be fixated to the meniscus 12 by using a needle to push theanchoring sutures 16, 18 through the top surface 50 of the meniscus, andthen through the body of the meniscus and out through the back surface54 of the meniscus, where the anchoring sutures 16, 18 may be tied,thereby fixating the unitary surgical device to the meniscus. Theunitary surgical device 10 of the FIG. 42 embodiment may be fixated in asimilar manner.

In addition, as shown in the embodiment of FIGS. 29A-29B, a flat base 21could be provided with a wedge or otherwise shaped mass of tissueregeneration material 22 fixed to the base. The base 21 could includetwo fixating members 15, 17 comprising, for example, two lengths ofsuture 16 g, 18 g. A third fixating member 77 could also be included inthe unitary surgical device. In the embodiment of FIGS. 29A-29B, thethird fixating member 77 comprises a backstop and a length of sutureaffixed to the mass of tissue regeneration material 22, with the lengthof suture extending through the mass of tissue regeneration material asin the embodiment of FIGS. 11-12.

As shown in FIG. 27, a unitary surgical device substantially like thatshown in FIGS. 28-29 may be provided with barbed darts affixed to theends of sutures to define the first and second anchors 16, 18. Theunitary surgical device 10 of the FIG. 27 embodiment may be fixated tothe meniscus 12 in a manner similar to that shown in FIG. 29, exceptinstead of tying the ends of suture for fixation, the barbed darts 16,18 may be pressed into the body of the meniscus to thereby fixate thedevice 10 to the meniscus.

The embodiment of FIGS. 30-31 is similar to the embodiment of FIGS.22-23 and 25-26, except in the embodiment of FIGS. 30-31, each anchor16, 18, 40, 42, 44, 46 includes a barbed dart at the end of a length ofsuture. To implant this embodiment, the anchors 16, 18, 40, 42, 44, 46are moved over and under the portion of the meniscus behind the void 70and the barbed darts are pushed into the body of the meniscus throughthe back 54 of the meniscus. The barbed darts are pushed in until theunitary surgical device is properly fixated. The barbs on the dartsprevent the darts from being pulled out.

The embodiment of FIGS. 32-33 is similar to that of FIGS. 20-21, exceptthat instead of using suture as the first and second anchors 16, 18,barbed darts are affixed to extend outward from the back 74 of the massof tissue regeneration material 22. To implant this unitary surgicaldevice, the upper and lower projections 80, 82 are moved over and underthe surfaces 50, 88 of the vascularized portion 72 of the meniscusbehind the void 70 until the barbed darts enter the face 76 of themeniscus at the back of the void 70 created during the meniscectomy. Thebarbs on the dart fixate the implant in place against the meniscus. Itshould be understood that although only one anchoring barbed dart 16 isillustrated in FIGS. 22-23, it is contemplated that more than a singleanchoring device may be used in this embodiment. In addition, althoughthe top panel 24 of the base 21 may be affixed to the mass of tissueregeneration material by adhesion, cross-linking, mechanical fixation orthe like, the top panel 24 can also be free from such connection and canbe surgically fixated to the body of the meniscus as described abovewith respect to the embodiment of FIGS. 20-21.

In the embodiment of FIG. 34, the first and second anchors comprisemating darts and holes. The darts extend upward from the bottomprojection 82 and the mating holes are in the upper projection 80. Thedarts are long enough to extend through the body of part of themeniscus. The embodiment of FIG. 34 may be fixated by placing the device10 in the void 70 in the meniscus, positioning the bottom projection 82under part of the meniscus so that the darts extend upward through themeniscus and exit the top of the meniscus. The top panel 24 of the base21 may then be pressed down so that the tops of the darts extend throughthe holes and lock the top and bottom portions of the base together andto the meniscus.

In the embodiment of FIGS. 35-36, the first and second anchors 16, 18comprise tacks, and an additional pair of tacks are provided as thirdand fourth anchors 40, 42. In the embodiment of FIGS. 35-36, the mass oftissue regeneration material 22 is affixed to the top panel 24 of thebase 21 by adhesive, cross-linking (chemical or physical) or throughmechanical means. The tacks are provided on both the upper and lowerprojections 80, 82. When implanted, the mass of tissue regenerationmaterial fits within the void 70 left after the meniscectomy, and theprojections 80, 82 are positioned over and under the upper and lowersurfaces 50, 88 of the meniscus 12, between the surfaces 76 and 54 ofthe meniscus. The tacks extend into the body of the meniscus between thesurfaces 76 and 54, thereby fixating the unitary surgical device 10 tothe meniscus.

In the embodiment of FIGS. 37-38, the unitary surgical device isimplanted in a manner similar to the other embodiments. The device 10 ispositioned so that the void 70 is substantially filled by the mass oftissue regeneration material 22. Then, the top panel 24 is moved toplace the upper projection 80 over the top surface 50 of the portion ofthe meniscus behind the void 70 and the bottom panel is moved to placethe lower projection 82 under the lower surface 88 of the meniscusbehind the void 70. The female locking member 18 is pushed upwardthrough the lower surface 88 and into the body of the meniscus, and themale locking member 16 is pushed downward through the upper surface 50into the body of the meniscus until at least part of the male lockingmember 16 is received in the female locking member 18, thereby fixatingthe device 10 to the meniscus.

In the embodiment of FIGS. 39-40, the device 10 may be fixated by firstimplanting the female locking member 18 using a hollow needle deliverysystem, like that described above for implanting the device 10 of FIGS.3 and 4. The female locking member 18 is pushed through the surface 76,through the body of the meniscus and out through the surface 54. Thesuture extends through this passageway and through part of the implant,such as through the mass of tissue regeneration material 22 and throughthe top panel 24 of the base. The device 10 may be moved into positionwith the mass of tissue regeneration material located in the void 70 andagainst the vascularized portion 72 of the meniscus. The male lockingmember 16 is then pushed into the female locking member, therebyfixating the unitary surgical device 10 to the meniscus 12.

The embodiment of FIG. 50 may be used either as a means of approximatingthe inner surfaces of a meniscal tear, as shown in FIG. 51, or as ameans of fixating a tissue regenerating implant after a partialmeniscectomy, as shown in FIG. 52. To approximate the surfaces of a tearas shown in FIG. 51, the base 20 (backstop element 19 in FIG. 50) may beinserted using a commercially available device such as a Mitek MeniscalApplier, as described above. Additional standard equipment may then beused to move the first and second anchors 16 a, 18 c through thenon-articulating outer surface 54 of the meniscus, up through the upperarticulating surface 50 of the meniscus, across the tear 14, and backinto the body of the meniscus until the anchors 16 a, 18 c are embeddedin the meniscus. To fixate a separate tissue regenerating implant asillustrated in FIG. 52, the unitary surgical device 10 of FIG. 50 may beinserted as described above, or could be inserted from the outer,non-articulating side of the meniscus. The anchors 16 a, 18 c could bepushed through the outer non-articulating surface 54 of the meniscus,through the body of the meniscus, up through the upper articulatingsurface 50 of the meniscus and through the overlying upper portion 80 ofthe top panel 24 of the implant. The anchors 16 a, 18 c may then bemoved across a portion of the upper surface of the top panel 24 of theimplant and back into the body of the outer portion 72 of the meniscusto fixate the implant in place.

An additional embodiment of a unitary surgical device is illustrated inFIG. 53. In this embodiment, the upper projection 80 has a plurality ofpre-formed holes along the outer edge. Each hole could thereby comprisea fixating member, as shown at 15 and 17 FIG. 53. These holes could bepre-formed in the base 21 so that the surgeon may easily and quicklysuture the unitary surgical implant 10 of FIG. 53 to the outer vasculararea 72 of the meniscus through the holes 15, 17, as shown in FIG. 53.To implant such a device, the a length of suture, shown at 90 in FIG.53, with a backstop, shown at 92 in FIG. 53, could be used. The backstop92 could be positioned against the outer arcuate surface 54 of themeniscus, and then the suture 90 could be stitched to both the unitarysurgical device 10 and the vascularized area 72 of the meniscus using,for example, a corkscrew needle (not shown). With such pre-formed holesin the unitary surgical device, there is little risk of damaging thedevice during implantation.

Additional surgical techniques can be employed in implanting surgicaldevice of the type described in copending U.S. patent application Ser.No. 10/195,794 entitled “Meniscus Regeneration Device and Method”(Attorney Docket No. 265280-71141, DEP-745) by Prasanna Malaviya,Herbert Schwartz, David Whalen, Mark Pelo, Phil Jenks, Pamela Plouharand Jerry Lower.

While only specific embodiments of the invention have been described andshown, it is apparent that various alternatives and modifications can bemade thereto. Moreover, those skilled in the art will also recognizethat certain additions can be made to these embodiments. It is,therefore, the intention in the appended claims to cover all suchalternatives, modifications and additions as may fall within the truescope of the invention.

1. A unitary surgical device for implantation in a patient for repairinga body tissue in the patient, the unitary surgical device comprising: afirst biocompatible anchor including at least one of the following: abioresorbable barbed dart; a bioresorbable tack; a bioresorbablebackstop; and a bioresorbable male locking member; a secondbiocompatible anchor including at least one of the following: abioresorbable barbed dart; a bioresorbable tack; a bioresorbablebackstop; and a bioresorbable female locking member; and biocompatibletissue repair material extending between and connected to the firstanchor and to the second anchor prior to surgery, the tissue repairmaterial including at least one of the following: a fixed length ofsuture; a sheet of collagen-containing material; a sheet of biologicallyremodelable collagenous matrix; laminar ECM material; formed ECMmaterial; comminuted ECM material; ECM fiber; ECM foam material;cross-linked ECM material; a sheet of bioresorbable material; and a baseand a different material secured to the base, at least one of the baseand the different material including ECM material.
 2. The unitarysurgical device of claim 1 wherein the tissue repair material includestissue regeneration material.
 3. The unitary surgical device of claim 2wherein the tissue regeneration material includes ECM material.
 4. Theunitary surgical device of claim 3 wherein the ECM material includesmaterial derived from mammalian submucosa.
 5. The unitary surgicaldevice of claim 1 wherein the ECM material includes material derivedfrom mammalian submucosa.
 6. The unitary surgical device of claim 1wherein at least one of the anchors is sized and shaped to bear againsta non-articulating surface of the meniscus of the patient.
 7. Theunitary surgical device of claim 1 wherein the tissue repair material issized and shaped to extend over a portion of patient's meniscus and toextend over an area from which a portion of the patient's meniscus hasbeen removed.
 8. The unitary surgical device of claim 1 wherein thetissue repair material is wedge-shaped in cross-section.
 9. The unitarysurgical device of claim 1 wherein the tissue repair material furtherincludes suture and a backstop.
 10. The unitary surgical device of claim1 further comprising a package holding the unitary surgical device.11-54. (Cancelled)
 55. A unitary surgical device for implantation in apatient for repairing a body tissue in the patient, the unitary surgicaldevice comprising: a first biocompatible anchor including at least oneof the following: a bioresorbable barbed dart; a bioresorbable tack; abioresorbable backstop; and a bioresorbable male locking member; asecond biocompatible anchor including at least one of the following: abioresorbable barbed dart; a bioresorbable tack; a bioresorbablebackstop; and a bioresorbable female locking member; and biocompatibletissue repair material extending between and connected to the firstanchor and to the second anchor prior to surgery, the tissue repairmaterial including at least one of the following: a fixed length ofsuture; a sheet of bioremodelable collagenous matrix; bioremodelablecollagenous tissue matrix having a density greater than 0.5 g/cm³connected to the first fixating mechanism and the second fixatingmechanism; bioremodelable collagenous tissue matrix having a densitygreater than 0.7 g/cm³ connected to the first fixating mechanism and thesecond fixating mechanism; bioremodelable collagenous tissue matrixhaving a density greater than 0.9 g/cm³ connected to the first fixatingmechanism and the second fixating mechanism; bioremodelable collagenoustissue matrix seeded with cells; bioremodelable collagenous tissuematrix combined with a biological lubricant; formed bioremodelablecollagenous tissue matrix material; pieces of bioremodelable collagenoustissue matrix; bioremodelable collagenous tissue matrix foam;cross-linked bioremodelable collagenous tissue matrix; a sheet ofbioresorbable material; and a base and a different material secured tothe base, at least one of the base and the different material includingbioremodelable collagenous tissue matrix. 56-64. (Cancelled)